Cleared Traditional

K202222 - Irrisept Wound Debridement and Cleansing System (FDA 510(k) Clearance)

K202222 · Irrimax Corporation · General & Plastic Surgery device

Dec 2020

Decision

130d

Days

Class 2

Risk

K202222 is an FDA 510(k) clearance for the Irrisept Wound Debridement and Cleansing System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).

Submitted by Irrimax Corporation (Lawrenceville, US). The FDA issued a Cleared decision on December 14, 2020, 130 days after receiving the submission on August 6, 2020.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number	K202222 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 06, 2020
Decision Date	December 14, 2020
Days to Decision	130 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF